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Proof of Biological Activity of SAR100842 in Systemic Sclerosis

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR100842
Placebo (for SAR100842)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

- Patients who meet the American College of Rheumatology (ACR) criteria for systemic sclerosis with diffuse cutaneous involvement and <36 months since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon and have a Modified Rodnan Skin Score (mRSS) ≥ 15 and an area of definite involvement of the dorsal forearm that is considered amenable to repeated 4mm skin biopsies.

Exclusion criteria:

  1. Patients with high dose or unstable low dose immunosuppressive drugs, cytotoxic, anti-fibrotic or glucocorticoids drugs at least 4 weeks prior to screening
  2. Serum creatinine > 2.0 mg/dL
  3. Gastrointestinal involvement preventing oral administration of study drug
  4. Severe cardiac and/or pulmonary disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 840006
  • Investigational Site Number 840003
  • Investigational Site Number 840004
  • Investigational Site Number 840001
  • Investigational Site Number 840002
  • Investigational Site Number 840007
  • Investigational Site Number 840008
  • Investigational Site Number 250003
  • Investigational Site Number 250001
  • Investigational Site Number 380001
  • Investigational Site Number 756001
  • Investigational Site Number 826001
  • Investigational Site Number 826002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR100842

Placebo

Arm Description

Core part: SAR100842 300 mg, oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks

Core part: Placebo (for SAR100842), oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks

Outcomes

Primary Outcome Measures

Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events

Secondary Outcome Measures

Change from baseline to Week 8 in biomarkers obtained from blood and skin
Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS)
Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score

Full Information

First Posted
July 24, 2012
Last Updated
February 26, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01651143
Brief Title
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Official Title
Double-blind, Randomized, 8-week Placebo-controlled, and 16-week Open-label Extension Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: - To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis. Secondary Objectives: To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor signaling markers in blood and skin; To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the modified Rodnan Skin Score (mRSS); To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ); To document long term safety of SAR100842 during the extension part.
Detailed Description
Core part: randomized, double-blind, placebo-controlled study - 8-week treatment Extension part for participants completing the core part: Open label non-controlled study - 16-week treatment Each patient's participation in the study will be approximately 13 or 33 weeks depending on their participation in the extension part: up to 2 weeks of screening, 8 weeks of treatment in the core part, 1 to 30 days wash-out between core part and extension part , 16 weeks of treatment in the extension part and 3 weeks of follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR100842
Arm Type
Experimental
Arm Description
Core part: SAR100842 300 mg, oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Core part: Placebo (for SAR100842), oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks
Intervention Type
Drug
Intervention Name(s)
SAR100842
Intervention Description
Pharmaceutical form: tablets Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Placebo (for SAR100842)
Intervention Description
Pharmaceutical form: tablets Route of administration: oral
Primary Outcome Measure Information:
Title
Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to Week 8 in biomarkers obtained from blood and skin
Time Frame
Day 1 and Week 8 (core part)
Title
Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS)
Time Frame
Day 1 and Week 8 (core part)
Title
Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score
Time Frame
Day 1 and Week 8 (core part)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : - Patients who meet the American College of Rheumatology (ACR) criteria for systemic sclerosis with diffuse cutaneous involvement and <36 months since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon and have a Modified Rodnan Skin Score (mRSS) ≥ 15 and an area of definite involvement of the dorsal forearm that is considered amenable to repeated 4mm skin biopsies. Exclusion criteria: Patients with high dose or unstable low dose immunosuppressive drugs, cytotoxic, anti-fibrotic or glucocorticoids drugs at least 4 weeks prior to screening Serum creatinine > 2.0 mg/dL Gastrointestinal involvement preventing oral administration of study drug Severe cardiac and/or pulmonary disease The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840006
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Investigational Site Number 840003
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Investigational Site Number 840004
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Investigational Site Number 840001
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Investigational Site Number 840002
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Investigational Site Number 840007
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Investigational Site Number 840008
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Investigational Site Number 250003
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number 250001
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Investigational Site Number 380001
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Investigational Site Number 756001
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Investigational Site Number 826001
City
London
Country
United Kingdom
Facility Name
Investigational Site Number 826002
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29732731
Citation
Allanore Y, Distler O, Jagerschmidt A, Illiano S, Ledein L, Boitier E, Agueusop I, Denton CP, Khanna D. Lysophosphatidic Acid Receptor 1 Antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis: A Double-Blind, Randomized, Eight-Week Placebo-Controlled Study Followed by a Sixteen-Week Open-Label Extension Study. Arthritis Rheumatol. 2018 Oct;70(10):1634-1643. doi: 10.1002/art.40547. Epub 2017 Nov 6.
Results Reference
derived

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Proof of Biological Activity of SAR100842 in Systemic Sclerosis

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